access to essential medicines - World Health Organization

ACCESS TO ESSENTIAL MEDICINES: IDENTIFYING POLICY RESEARCH AND CONCERNS

August 2011 Shehla Zaidi & Noureen Nishtar Department of Community Health Sciences Aga Khan University, Karachi Funded by Alliance for Health Policy and Research, World Health Organization, Geneva

The Aga Khan University | Access To Essential Medicines Pakistan |August 2011

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ACCESS TO ESSENTIAL MEDICINES: IN PAKISTAN IDENTIFYING POLICY RESEARCH AND CONCERNS


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ACKNOWLEDGEMENT This report would not have been possible without the participation provided by a range of stakeholders. Their time commitment, candid sharing of information and thoughtful perspectives are gratefully acknowledged. In particular we would like to thank the Federal Ministry of Health, National Health System & Policy Unit, Department of Health Sindh, Department of Health Punjab, President’s Primary Health Care Initiative, Pakistan Medical Association, Pakistan Pharmacists Association, Pakistan Pharmacy Council, Pakistan Pharmaceutical Manufacturer’s Association, Bio-Equivalence Centre Lahore, Experts and NGOs. The study was a result of close collaborative work with Eastern Mediterranean Regional partners, Dr. Arash Rashidian at Tehran University of Medical Sciences and Dr.Samer Jabbour at American University Beirut. Valuable facilitation and feedback was provided during data collection and synthesis by Khalid Bukhari Coordinator Essential Medicines WHO Pakistan and Dr. Guido Sabatinelli WHO Representative Pakistan. Technical guidance was provided by Maryam Bigdeli at the Alliance for Health Policy System Research, Geneva. Funding support was granted by Alliance for Health Policy & Systems Research- World Health Organization, Geneva and is gratefully acknowledged. The study was conducted by the Department of Community Health Sciences of Aga Khan University, Karachi.

Authors: Dr Shehla Zaidi - Country Investigator, Pakistan Noureen Nishtar - Research Coordinator

The correct citation for this report is: Zaidi S, Nishtar NA (2011). Access to Medicines: Identifying Policy Concerns and Policy Research Questions, Research Report, Aga Khan University Karachi and the Alliance for Health Policy & Systems Research – WHO Geneva.


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TABLE OF CONTENTS ACRONYMS ....................................................................................................................................... vi ABSTRACT .......................................................................................................................................... 1 EXECUTIVE SUMMARY .................................................................................................................... 2 COUNTRY PROFILE ........................................................................................................................... 6 SECTION 1: BACKGROUND............................................................................................................ 7 SECTION 2: METHODOLOGY ........................................................................................................ 8 SECTION 3: RESULTS OF DESK REVIEW.................................................................................. 10 SECTION 4: RESULTS OF STAKEHOLDER INTERVIEWS ..................................................... 27 SECTION 5: RESULTS OF ROUNDTABLE .................................................................................. 31 SECTION 6: DISCUSSION .............................................................................................................. 33 References ........................................................................................................................................... 38 Search Strategy .................................................................................................................................... 45


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ACRONYMS AHPSR ATM AUB BHUs CSOs DFID DHQ DOH EDL EMRO GMP GPs HAI HIV LMICs MDG MOH MPR NHA NPPI OECD PDHS PMDC PPHI PSLM RHCs THQ TRIPS TUMS WHO

Alliance for Health Policy & System Research Geneva Access to Medicine American University Beirut Basic Health Units Community Service Organizations Department for International Development UK District Headquarters Department of Health Essential Drug List Eastern Mediterranean Regional Office Good Manufacturing Practices General Physicians Health Action International Human Immunodeficiency Virus Low and Middle income Countries Millennium Development Goal Ministry of Health Median Price Ratio National Health Accounts Norwegian Pakistan Partnership Initiative Organization for Economic Cooperation and Development Pakistan Demographic and Health Survey Pakistan Medical and Dental Council Presidents Primary Health Care Initiative Pakistan Social and Living Standards Measurement Survey Rural Health centers Tehsil Headquarter Trade-Related Aspects of Intellectual Property Rights Tehran University of Medical Sciences World Health Organization


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ABSTRACT The fundamental importance of ensuring access to medicines, particularly for the poor, is reflected in MDG 8 however remains poor in many low and middle income countries (LMICs). Country specific evidence on access to medicines is weak in LMICs and research has rarely been from an integrated health systems perspective. This study used an evidence based approach to identify key priority concerns and emerging research questions related to access to medicines in Pakistan. WHO’s Access to Medicine Framework was used as the conceptual basis for data collection on rational usage, affordability, financing and health systems. Methods involved a systematic desk review, in-depth stakeholder interviews and a consensus building Roundtable exercise. In Pakistan there has been considerable work in terms of medicines related policy acts and operative guidelines. However considerable gaps exist between policy and practice and between medicine policies and health systems strategies. Average number of medications prescribed is higher than other LMICs and prescription practices frequently do not follow standard recommended therapies from specialists down to general practitioners. There is a widely entrenched private informal sector and shadow pharmacies which remains largely unregulated. Spending on drugs is mainly borne by households, accounts for 63% of total spending on drugs in Pakistan as compared to only 18% in OECD countries and can lead to catastrophic household expenditure. Medicine therapy for chronic care is particularly unaffordable even with use of low cost generics. Within the public sector, availability of essential generics is extremely low at 3.3% as compared to 29-54% in LMICs. Public sector spending on drugs is far below the minimum $2 per capita indicated for LMICs and existing spending faces issues of questionable adherence to EDL, low quality drugs and outdated logistics management systems. Contracting out the management of BHUs has resulted in better medicine availability. There is serious shortage of trained manpower pharmacists across private and public sector with 0.9 pharmacist / 100000 population in Pakistan far below recommended ratio of 1 pharmacist per 2000 population. Drug regulation also requires with registration of excessive number of drugs, wide quality variation in quality and pricing, and frequent instances of spurious drugs and black marketing. Chronic shortage of low prices essential medicines is a long standing issue linked to disincentive to production due to low pricing and flat price control. The above policy concerns raise need for research in key areas. First, there is need for surveys on continuous surveillance of policy impact on availability, price and affordability of medicines; mapping of private informal sector and shadow pharmacies; and consumer health seeking preferences. Second, collation is required of best practice lessons on registration, pricing, market vigilance and enhancement of rational drug use. Third, operation research pilots in key areas such as alternative health financing mechanisms involving commodity voucher, GP contracting, pre-payment schemes, equity funds for increasing drug availability and affordability; scientific improvement of logistics management system in public sector; and introducing community participation in accountability mechanisms. Pharmaceutical policy and research needs to be centrally placed within larger health systems related initiatives. It needs to be accompanied by sustained dialogue and interaction between multiple stakeholders including private sector. Adequate steps also need to be taken to ensure a continuous culture of research feeding into evidence based policies.


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EXECUTIVE SUMMARY Background: The fundamental importance of ensuring access to medicines, particularly for the poor, is reflected in MDG 8 however access and appropriate use of medicines remains poor in many low and middle income countries (LMICs). WHO estimates that the average availability of essential drugs in LMICs is only 35% in public sector facilities and 66% in the private sector, and that medicines account for a high proportion and between 20% – 60%, of health spending in LMICs as compared to 18% spending in developed countries with substantial costs often borne by households Even where medicines are available, there are concerns of drug quality and inappropriate prescription. Research on improving access to medicines has not been an integral part of health systems research. Data on access to and use of medicines is often weak and country specific context on medicine policies and practices is often missing. In an attempt to increase use of evidence in policies so as to make them more responsive to local country needs, a policy exploratory study on “Identification of Policy Concerns and Research Questions related to Access to Medicines” was conducted in Pakistan, Iran and Lebanon in the Eastern Mediterranean Region as well as 16 other countries in different WHO regional clusters. These priority setting studies are part of a larger global research initiative on Access to Medicines (ATM) being implemented by Alliance for Health Policy and Systems Research WHO Geneva and funded by the UK Department for International Development (DFID). The Study: The Pakistan Priority Setting project, which is the subject of this report, had two fold objectives: i) to identify Pakistan specific policy concerns related to access to and use of medicines, as perceived by policy makers, civil society organizations and patients and communities; and ii) based on evidence generated to identify emerging research questions. The study was implemented over a six month period and involved a systematic desk review, in-depth stakeholder interviews as a consensus building Roundtable exercise for prirotization of emerging issues and research concerns. The Pakistan report provides an agenda for country level action –policy concerns for a range of government and non-government stakeholders as well as researchable areas for researchers, Alliance HPSR, other research funding entities and policy makers. It also attempts to bridge the gap between pharmaceutical sector and health systems by integrating responses with health financing, human resource planning, service delivery, information and governance systems. Salient Findings: In Pakistan there has been considerable work in terms of Policy Acts, legislations, detailed regulatory and operative guidelines for the pharmaceutical sector. It is one of the first countries in which the Essential Medicine Program of WHO was initiated in the 1970’s and has a National EDL comprising of 335 medicines. The industry has grown from hardly any production unit at the time of Independence to 414 local and 30 multinational drug production companies in Pakistan. Drugs are exempt from sales tax and a flat price control is in place for the last decade in an attempt to increase access of the poor to medicines. However considerable gaps exist between policy and practice leading to high expenditure on drugs by the poor, widespread quality concerns on drugs, widespread inappropriate prescription practices and low drug availability in the public sector facilities. There is dire need for update of policies in line with on ground evidence and infusion of an innovative mix of policy measures. Policy Concerns: Medical practitioners, including both GPs and specialists, often prescribe unnecessary number of medications with average for Pakistan being >3 medicines per prescription as compared to 2-3 in LMICs and injection usage rate one of the highest in the world. Additionally, population in Pakistan frequently utilizes quacks and informal providers and there is also considerable self medication with indicative figures are of 30-55%. As a result of irrational drug use, drug expenditure borne by households is one of the highest in LMICs, drug resistance The Aga Khan University | Access To Essential Medicines Pakistan |August 2011

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to first line antibiotics has been documented at least in urban Pakistan, and frequent injection usage has been linked to the high prevalence of Hepatitis B and C in the population. There are several contributing reasons for irrational drug use requiring integrated action at multiple tiers of the health systems. These include poor training and enforcement of standard therapies in the medical sector, unrestricted interaction of industry with practitioners, loose regulation of private informal sector and shadow pharmacies, and registration of unnecessary number of drugs. Successful examples of GP training and franchising for appropriate treatment have long been in place by CSOs but have not been replicated by government. 63% of total drug expenditure is borne by households, one of the highest in developing countries, as opposed to only 18% in OECD countries and leads to non-compliance with chronic care treatment and risk of catastrophic expenditure. Low spending by public sector forces patients utilizing ‘free’ public sector facilities to private retail outlets. Medicine therapy for chronic care is clearly unaffordable even with use of low cost generics (MPR of 1.7-7.7) while it can be dangerously expensive with originator brands (MPR of 1.9-36.4). In affordability of medicines has been documented as one of the primary reasons for loose compliance with chronic care therapy. Availability of essential generics is extremely low in public sector 3.3% in public sector compared to 29-54% in LMICs. Reasons for frequent drug stock-outs have not been properly investigated but are attributed to a combination of low budget, lack of rational procurement and delayed release of funds. Contracting out management of BHUs has resulted in better medicine availability in public sector. There has been limited attention to management of drugs supply in the public sector with issues of low quality and logistics management. Low quality threshold in purchase of drugs, lack of scientific forecasting, budgeting and procurement, traditional logistic management systems and poor storage facilities need attention. Private retail outlets are the predominant means to supply to both private and public sector patients however the existence of close to 80,000 drug stores, one of the highest in developing countries, defeats attempts at regulation. Only a fifth of all retail outlets meet licensing requirements and are mostly manned by untrained persons rather than pharmacists. There is shortage of trained human resource across public and private sector for drug procurement, management and dispensation. As opposed to WHO’s recommended ratio of 1:2000 pharmacists per population, Pakistan has only 0.9 pharmacists per 100000 population, of which 70% are engaged in industry with a very small core serving in health service delivery. Pakistan produces 70% of consumed medicines however close to 50% of the market belongs to multinationals and is far from achieving self-sufficiency in production. Self-sufficiency in tem of raw material production is yet to be achieved with dependence essentially on imports and assistance needs to be provided to local companies for making use of patents available through TRIPS. Pakistan has 76000-88000 registered drugs, one of the highest numbers in LMICs, with many being unnecessary drugs having marginal therapeutic effect over each other or multiple variations of the same drug available at different prices and quality. There are wide discrepancies in terms of quality of registered products with little incentive for more sophisticated production units to invest in quality control. An autonomous Drug Registration Authority to counter poor drug quality has been endorsed but still needs to be put into practice. Market vigilance needs strengthening as counterfeit medicines and black-marketing with creation of artificial shortages is common in Pakistan. New modalities of control are needed with move to more participatory and incentive based policies to overcome existing nexus of corruption in the existing hierarchal control system. The Aga Khan University | Access To Essential Medicines Pakistan |August 2011

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Flat price control is in practice and although well intentioned is also counterproductive resulting in disappearance of low cost essential medicines, even life saving drugs, from the market, little impact on high priced items, and a general disincentive to producers. Targeted action is instead needed on identification and tight control of standard treatment for chronic care drugs, life saving drugs and those drugs that are excessively priced. A clearer pricing formula is also needed to reduce opportunity for collusion and inefficient market spending on products. Greater participation of implementers is needed in regulation however move to totally devolve drug registration to provinces as part of ongoing devolution of Ministry of Health may have serious repercussions due to uneven regulatory capacity of provinces and potential creation of inequities across provinces with differential drug availability and prices. Institutional realignments need to be directed towards creation of an autonomous drug regulation authority but built along more participatory lines. Research needs for addressing policy concerns: There is high need for evidence generation to assist action on prioritized policy concerns. So far research in the pharmaceutical area in Pakistan has been occasional, mostly confined to rational prescription while areas such as policy, supply side and financing have largely been underexamined. Key research priorities were identified through the consensus building exercise and salient features are given as follows: Continuous surveillance is needed into effect of national policies on medicine availability, prices and affordability covering both the market and the public sector. It is internationally recommended that such surveys should be repeated periodically every two years however there has been no updating of information since the last WHO global survey in 2004. Quality monitoring and pharmaco-vigilance of market products is required accompanied by compilation of best practice lessons from other countries on new strategies. Pricing policies require examination to improve access to essential generics particularly for standard chronic care therapy and contain prices of excessively priced originator brands. Bottlenecks faced by the Essential Medicines Programme in Pakistan need to be examined to reduce the gap between policy and practise with targeted interventions for promotion of generics at policy level, supply side level, individual provider levels and consumer level. Examination of alternative financing mechanisms is required to reduce medicine expenditure borne by households particularly on chronic care therapy, and supplement public sector provision. Possible mechanisms include franchising with GPs, contracting with NGOs, commodity vouchers, health equity funds and pre-payment schemes, to supplement public sector provision. Standardised mapping and assessment surveys of private sector are required including of qualified providers, informal providers, shadow pharmacies, and traditional healers. Formative research is needed into consumer demand, health-seeking preferences, willingness to pay, and enhancing patient role in accountability. Finally operation research is also needed into improving logistics and human resource management in the public sector for improving drug access. Successful examples from INGOs and donor funded projects can be tested into the public sector. Way Forward: Pharmaceutical policy and research need to be centrally placed within larger health systems related initiatives, reviews and policy updates. Action is particularly needed on following priority areas:


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      

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Continuous surveillance of impact of policies on availability, price and affordability Identification, regulation and monitoring of standard chronic care therapies that would particularly benefit from reduced pricing and wider availability. Optimal mix of pricing regulations to reduce expenditure burden on households. Tighter regulatory control to cut down on unnecessary medicines having marginal therapeutic effect over each other. Market vigilance for spurious drugs and participatory strategies to counter spurious drugs Multi-tiered health system measures for promotion of generics Operation pilots on alternative financing mechanisms to supplement public sector through a range of commodity voucher, GP contracting, pre-payment schemes, equity funds for increasing drug availability and affordability Mapping of private sector and exploring support needs for rational use Consumer health seeking preferences and participation in accountability mechanisms Improvement of logistics and human resource management in public sector for drug access

This needs to be accompanied by sustained dialogue and interaction between entities including public health sector, pharmacists association, medical doctors association, local governments, industry, researchers and development partners. Adequate steps also need to be taken to ensure access to research, feedback on research and a continuous culture of research feeding into evidence based policies.


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COUNTRY PROFILE Pakistan is situated in the North-Western part of South Asia, with about 185 million people and annual population growth rate is 1.9% .It is bordered by China on the northeast side, India on the eastern side, Iran and Afghanistan on the western side and the Arabian Sea on its south. The GNP per capita is $1200 and 1% is spent on health.

Life expectancy in Pakistan is 63 for males and 65 for females. Maternal mortality ratio is 276, infant mortality rate is 74 and under five mortality rate is 98 (PDHS 2006-07). Total fertility rate in Pakistan is 4.1, 3.3 in urban and 4.5% in rural areas and CPR is 30%, whereas unmet need of contraception is 25%. (PDHS 2006-7). At the same time Non Communicable Disease burden in Pakistan is also high and accounts for 59% of the forgone DALYs while the remaining 41% disease burden is due to communicable diseases and maternal, child care and nutritional issues (World Bank 2011). In recent years natural disasters have also had a detrimental effect on health status. 75,000 people died in the 2005 earthquake and 1,810 in the 2010 floods but asides from fatality these disasters resulted in widespread communicable diseases and destroyed the health care infrastructure and peoples’ livelihoods in affected areas. Health care provision in Pakistan comprises private and public services. Although the public sector has a well developed infrastructure of primary, secondary and tertiary facilities as well as an outreach Lady Health Worker Program, public sector is under-utilized and serves 21% of the population (WHO-EMRO 2011). The private sector serving nearly 79% of the population is primarily a fee for service system and covers the range of health care provision from commercial private sector, CSOs, philanthropic institutions and traditional faith healers. Under Pakistan’s constitution, health is primarily the responsibility of the provincial government, except in the federally administrated areas. Ministry of Health (MOH) at the Federal level has played the major role in developing national policies and strategies, hosts 11 vertical programs and also the Drug Control Organization. Under a recent constitutional amendment the Federal MOH along with a number of other ministries is to be devolved to the provinces in 2011 with retaining of a minimalist MOH under the Cabinet Division. Areas and functions to be devolved to provinces are as yet unclear.


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SECTION 1: BACKGROUND Introduction: The provision of reliable access to affordable, appropriate and high-quality medicines is a key component of a functioning health system (WHO 2007). Access to medicines needs to be fully integrated with health financing, human resource planning, service delivery, information and governance systems. Access to and appropriate use of medicines is often poor in low and middle income countries (LMICs). WHO estimates that the average availability of essential drugs in LMICs is 35% in public sector facilities and 66% in the private sector (MDG 2008). Medicines account for a high proportion, between 20% – 60%, of health spending in LMICs as compared to 18% spending in developed countries (Cameron 2009). Moreover, between 50% - 90% of expenditure on medicines in LMICs is out-of-pocket (WHO 2004a). This inequitable mode of financing creates significant access barriers for the poor and/or may lead to catastrophic household expenditures. The poor as well as other population groups often rely on the private informal sector for medicines, particularly in rural areas. Over and inappropriate prescription and dispensing of medicines are prevalent (WHO 2008). Despite some progress in some areas - such as price and availability - , data on access to and use of medicines is often weak (WHO 2004a). Even where data are available, there is limited contextual evidence and analysis to assist in interpretation or in the development of policy options to improve access to medicines in different health systems and country settings, especially for LMICs. Health Systems Research (HSR) is essential to understanding, planning, monitoring and evaluating access to medicines and importance of HSR was confirmed by the High Level Forum task team report at the Global Ministerial Forum on Research for Health in Bamako in 2008 (WHO 2009). The Study: The Access to Medicines (ATM) Policy research is a new program of work, implemented by the Alliance for Health Policy and Systems Research (AHPSR), WHO Geneva and funded by the UK Department for International Development (DFID). The program aims at improving the availability and use of evidence on access to medicines in Low and Middle Income countries, particularly for the poor (MDG 8) by increasing the use of evidence in policies to improve access to and use of medicines. The Prioritization Study is one of the studies being conducted under the broader ATM project, and is being simultaneously implemented in 19 countries. Its objectives are two fold, to  Identify and rank, to the extent possible, country level (PAKISTAN) policy concerns related to access to and use of medicines, as perceived by policy makers, civil society organizations and patients and communities  Identify and rank, to the extent possible, related policy research questions in the field of access to and use of medicines in PAKISTAN. The findings are intended to forge an evidence based link to medicines policy and health policy in Pakistan and the EMR region. Other planned activities under the larger ATM project include research grants for multi-site studies on access to medicines; systematic reviews, syntheses and overviews; policy briefs; evidence to policy activities, and dissemination activities. Partners: The Pakistan priority setting study is part of a larger EMR project involving three country specifics studies for Iran, Pakistan and Lebanon and a review of Eastern Mediteranean Region. Aga Khan University Karachi is the institute responsible for the Pakistan study in collaboration with the Tehran University of Medical Sciences (TUMS) the lead partner for the EMR region and for the Iran country study, University Beirut (AUB) partner institute for Lebanon, and Alliance HSPR-WHO for funding and overall technical direction.


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SECTION 2: METHODOLOGY The WHO Framework for Access to Medicine (WHO 2002) was used as the basis for data collection and synthesis. Under this framework accessibility has been defined as having four parameters: that the available medicines are effective and of consistently good quality, that there is no financial obstacle to a patient receiving it, and that required knowledge and guidance are available for proper use of these medicines Any isolated effort to improve one part may be effective for that part but it would not improve the overall situation. Improving Access to Essential Medicines: A Framework for Collective Action in Line with Millennium Development Goals

1. Rational Drug Use

3. Sustainable Financing

ACCESS 2. Affordable Prices

4. Reliable Health Systems

Source: Richard Laing, Improving Access to Child Health Medicines, Review and Discussion Paper, WHO Regional and Country Child Health Advisers, Geneva, 2002

The methods involved desk review, stakeholder interviews and consultative prioritization through Roundtable. Desk Review: This involved published studies, unpublished studies and grey literature such as commissioned reports and surveys. A total of 11706 titles were yielded using the electronic search and reference from bibliographies. These were sifted by 2 researchers for identification of relevant studies. A total of 184 studies were shortlisted. Abstracts and report summaries of 184 studies were reviewed and a total of 96 studies were further short-listed. The full text of all these 96 studies, including articles, reports, presentations and books was then reviewed and 92 studies were selected and uploaded into EndNote In addition 19 policy documents were also included through a system involving online search as well as opinion taken from experts. Identification and access to other policy documents that are not in public domain were sought during stakeholder interviews. Data from each reviewed study and policy documents was systematically extracted and analyzed using grids based on the WHO Access to Medicines Framework under the four domains of rational use, affordability, financing, and reliable health systems. Details of search strategy and analysis of desk review is presented in Annex. Stakeholder Interviews: 21 in-depth interviews were conducted involving a diverse range of stakeholders. Purposive sampling was done and the list of stakeholders was developed in a 2 step consultative process. In a meeting of regional partners at Tehran University a matrix was developed mapping major organizational backgrounds for stakeholder selection across all the three participating EMRO countries. These included MOH The Aga Khan University | Access To Essential Medicines Pakistan |August 2011

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and its entities, CSOs (as patients’ representatives), medical associations (as clinician representatives), pharmacists associations (as pharmacists representatives), industry, research institutions, development partners etc (see attached stakeholder matrix). These would be consistent for all 3 countries but identification of specific names and exact numbers would be done by country team. Subsequently a meeting was held of Pakistan team with WHO Pakistan for identification of specific interviewees under each organizational category. Ethical approval was obtained prior to interviews. Written informed consent was obtained from each interviewee and written project information and contact details of investigators were provided. Written assurance was also given of confidentiality of interviewee identity in making reference to interview results. Interviews were conducted in Islamabad, Karachi and Lahore. Interviews notes were taken by a two member team and transcribed and compared between note takers on same day. Interview analysis was done manually and the WHO 2002 Access to Medicine Framework was taken as the conceptual framework for analysis. Mapping of Key Stakeholders Ministry of Health  Director General Health  Officials Licensing & Registration Board

Development Partners  WHO  GAVI Research Institution  Bio-Equivalence Centre, Lahore

Department of Health  Additional Secretary Technical, DHO  Executive District Health Officer  Additional Medical Superintendent, Tertiary hospital  Chief Pharmacist, Tertiary Hospital  Drug Inspector Pharmaceuticals  Pakistan pharmaceutical Manufacturing Association CSOs  Merlin  Consumer Protection Network

Other Providers  President Primary Healthcare Initiative, Sindh

Pharmacies / Other Provider  Pakistan Pharmacists Association  Director Pharmacies, AKU Clinicians  Pakistan Medical Association

Consensus Building: A consultative process was taken for identification of policy and research concerns. A Roundtable with stakeholders was held on 12th May at AKU Karachi involving 25 stakeholders from different entities attended the meeting including country Investigators from Iran and Lebanon as well as focal person for ATM project from Alliance HPSR, WHO Geneva. The Roundtable was chaired by Secretary Health, Sindh, Pakistan. The roundtable took a consultative process to identify emerging policy concerns and research questions. It involved presentation of scope and objectives of ATM prioritization project being carries out globally, brief overviews of findings from Iran and Lebanon and detailed presentation on Pakistan findings. Following the presentation, policy concerns were collectively identified and a list of research questions generated for further action. Written comments were further invited posts Roundtable through an email listing for improvement of data and incorporation of needed research areas.


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SECTION 3: RESULTS OF DESK REVIEW I. RATIONAL USE OF MEDICINES IN PAKISTAN Irrational drug prescribing, dispensing and self-medication continue to be a major problem in Pakistan. Although a national essential drug list exists it is poorly enforced across the health sector. Irrational prescription is due to high level of prescription by non-qualified practitioners and self medication, frequently inappropriate prescription particularly by qualified providers, particularly high use of injectables, and resulting issues of polypharmacy, unnecessary expenditure, drug resistance, and contributing to high prevalence of Hepatitis B and C in the country. National Essential Drug List: Essential medicines as defined by WHO are those that satisfy the health care needs of majority of the population. Through 1970s and 1980s the Essential Medicines Program of WHO Pakistan promoted this concept to redress imbalance in selection of drugs. The National Essential Drug List (EDL) of Pakistan was first prepared in 1994 in consultation with relevant experts and using WHO’s model list of Essential Medicines as a template. The list was subsequently reviewed in 1995, 2000 and 2003 and the present list is the fourth revision containing 335 medicines (MOH 2007). Development of EDL is a function of the Federal Ministry of Health (MOH) while compliance and adherence rests with the provincial Departments of Health (DOH). Procurement of drugs in DOHs is based on EDL although non-EDL purchasing has been reported (details in supply side issues). Compliance and adherence to EDL varies from poor to good in different parts of Pakistan (DFID 2002; Najmi et al 1998; Das 2001). In a baseline survey in three provinces of Pakistan, it was found out that EDL is only available in one out of five public sector facilities (DFID 2002). Compliance with EDL in terms of prescriptions was found to be 50% at public sector facilities in one survey (Das 2001) and 80% in a survey of three public sector teaching hospitals (Najmi et al 1998). Frequent prescription by non-qualified prescribers: Prescription by non-qualified practitioners as well as selfmedication is common in Pakistan; however there are few studies that capture the magnitude of self-medication and hardly any literature on quacks. In a survey of 500 households examining health seeking behavior for childhood illnesses, self-medication for childhood illnesses was seen in 51.3% children (Haider &Thaver, 1995). These mostly comprised of analgesics/antipyretics (25%), anti-diarrheals/ anti-emetics (11%) and antibiotics (11%) while 34% were unidentified drugs (34%). Infants were self medicated particularly during diarrheal episodes, which is a dangerous trend as improper management has resulted in childhood diarrhea being the number two cause of death in children under five (Haider & Thaver 1995). A study on youth reported frequent prescription and consumption by college students on medical student’s advice or self prescription (Zafar et al 2008a). 55.3% of medical students prescribe medicines independently and most are likely to belong to 1st and 3rd year of medical college while a third of non-medical students report self prescription (Zafar et al 2008a&b). Another study pointed out that most potent drugs like antibiotics, psychotropic, narcotics, anti-cancers and hormones are being misused by un-trained doctors or by quacks or through self medication due to lack of coordination among the relevant professionals (Das, 2001). High level of inappropriate prescription by qualified providers for non communicable diseases: Drug Prescriptions amongst general practitioners (GPs) for chronic diseases also need significant rationalization. Similarly, a survey of 1000 GPs in Karachi reports that appropriate therapy for hypertension in elderly was initiated by only 35% of GPs while thiazide diuretics, internationally recommended as first line regimen, were rarely prescribed (4.2%) (Jafar et al 2005). Alarmingly, sedatives were commonly used either as first-line medication for lowering BP (23.8%) or in combination with antihypertensive agents (45%). A facility based study was conducted on eight fifty six patients to assess pharmacotherapy-based problems in the management of diabetes mellitus (Ali N et al, 2010). It was found out that there was a poor correlation between the advised insulin therapy and patients’ fasting blood glucose levels (12%, n=103) was observed. To most of the patients (41.66%, n= 357), insulin therapy was advised in combination with glucocorticoides, thiazides diuretics, and The Aga Khan University | Access To Essential Medicines Pakistan |August 2011

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propranolol, which are contraindicated due to drug interactions (Ali N et al, 2010). In facility based study on 186 patients in Karachi to assess the general practitioners (GP) knowledge regarding the diagnosis and initial drug therapy for acute myocardial infarction (AMI), the GPs were not giving initial drug therapy and were less likely to carry management for acute myocardial infarction(Ali M et al 2009). In another study on mental health, the treatment for psychiatric and paediatric illnesses did not correlate to diagnosis in 25% of cases and doses of drugs were inappropriate in 31% prescriptions (Najmi et al 1998). High level of inappropriate prescription by qualified providers for communicable diseases: A longitudinal cohort study was conducted on 200 patients at Camp Hospital Batagram to ascertain the effect of Zinc utilization in tablet and suspension formulations on the frequency and recovery rates of diarrhoea among young children (Bhuttta ZA 2010). It was found out that significant p-values were established among Zinc use and reduction in frequency of stools on Day 2 and 3, with better outcome in the group using Zinc in suspension form (Bhuttta ZA 2010). Although tuberculosis is an endemic disease and Pakistan has a national TB control program there is frequent variation from the recommended treatment. A survey of 88 GPs in Kyber Pukhtoonkhwa and Northern Areas of Pakistan showed that only 3.4% GPs knew all the components of DOTS, only 35% were able to write a prescription with correct drugs, dose and duration for initial phase and 30% for continuation phase of the therapy (Shehzadi et al 2005). In major urban centers, of the 120 private general practitioners surveyed, only half of respondents could prescribe ethambutol or pyrazinamide in the correct doses or for the correct duration (Khan et al 2003). In a survey on 245 medical practitioners on knowledge and practice regarding Tuberculosis diagnosis and treatment in Rawalpindi, only 1 of the 245 physicians was aware that cough > 3 weeks alone is the main symptom suggesting pulmonary TB. None of the practitioners were following National TB Control guidelines for prescribing drugs and none ensured compliance with anti-TB treatment under supervision of a doctor/health worker (Shah S 2001). Likewise in a cross sectional study on 151 GPs in private and public clinics of Karachi regarding practices among the general practitioners (GPs) of Karachi regarding dog bite management only 19.4% GPs had appropriate knowledge about the first line treatment. Almost all GPs (98%) had no knowledge about the types of anti-rabies vaccine and only 19.2% knew about anti-rabies serum (Faraz S 2009). A multi-center study was carried out to assess the treatment pattern in upper respiratory tract infections mostly of viral nature, revealed an alarming 88.9% rate of antibiotic prescription for these self-limiting infections (Ahmed Z 2005). While GP prescriptions are frequently inappropriate those of specialists have also been reported to be questionable. Little difference was seen in practices of GPs and specialists in treatment of childhood diarrhea. It was observed that only 17.7% of GPs and 14.3% of pediatricians prescribed ORS in all of their encounters while instructions for preparing ORS were given in only 6% of encounters by GPs and 8.4% of encounters by pediatricians (Nizami et al 1996). A significant difference was observed only in higher prescription of anti-diarrhoeals by GPs over pediatricians (P < 0.01) while there was no significant difference in antibacterial amongst GPs and pediatricians (P